Regulations have just gone into effect in the EU regarding the sale of herbal products. The regulations seem reasonable, but they have sparked near hysteria on the part of herbal sellers and advocates of “natural” medicine. They are calling the regulation a “ban” on herbal products, which much of the media has parroted, but it is not a true ban, just a requirement for registration.

The law was sparked by cases of toxicity from over-the-counter herbal products. For example, aristolochia is a toxic plant species that is either used deliberately or can be accidentally or carelessly substituted for other plant species. It is known to cause kidney damage – even leading to kidney failure is some cases. Another herb, kava, has been linked to liver damage.

The new EU law, which went into effect May 1, 2011, will require herbal products to be licensed, or prescribed by a licensed herbal practitioner. In order to be licensed evidence for safety of the product must be presented. It is estimated that it will cost between 80,000 and 120,000 British pounds to get an individual herbal product licensed.

One theme that we at Science-Based Medicine keep revisiting again and again is not so much a question of the science behind medical therapies (although we do discuss that issue arguably more than any other) but rather a question of why. Why is it that so many people cling so tenaciously to pseudoscience, quackery, and, frequently, conspiracy theories used by believers to justify why various pseudoscience and quackery are rejected by mainstream science and medicine? Certainly, I’ve touched on this issue before on several occasions, for example, with respect to the anti-vaccine movement, the claim that abortion causes breast cancer, and how we as humans crave certainty.

It turns out that science and science-based medicine are hard for humans to accept because they often conflict with what our senses perceive and brains interpret as irrefutable evidence. The pattern-seeking function of our brain, when evaluating questions of causation in medicine, frequently betrays us. For instance, when a parent sees her child regress into autism sometime not long after being vaccinated, the easiest, most instinctive, and most emotionally compelling conclusion is that the vaccine must have had something to do with it. When scientists tell her that, no, in large studies looking at hundreds of thousands of children, there is no good evidence that vaccination confers an increased risk of autism and a lot of evidence that it does not, it’s a very hard message to believe, because it goes against how the parent interprets what she’s seen with her own eyes. Indeed, how often have we seen believers in the vaccine-autism link pour derision on the concept that when something like autistic regression happens in close temporal proximity to vaccination that the correlation does not necessarily equal causation? Similarly, believers in “alternative medicine” who experience improvement in their symptoms also pour derision on the observation, explained so well by R. Barker Bausell in Snake Oil Science, that people frequently take remedies when their symptoms are at their worst, leading them to attribute natural regression to the mean to whatever nostrum they started taking at the time.

The First Amendment of the United States of America, guaranteeing freedom of speech

“Health freedom.” It’s a battle cry frequently used by supporters of “alternative” medicine against what they perceive to be persecution by the medical and scientific establishment that uses the Food and Drug Administration, the Federal Trade Commission, and other federal agencies charged with regulating pharmaceuticals, food, cosmetics, and medical devices in order to protect the public against fraud, adulterated food, and quackery. It’s a potent argument to those not versed in skepticism and science-based medicine, and even to many who are. After all, Who could argue with “health freedom”? How dare the government tell me what I can and can’t use to treat my own body? Of couse, as I (and others) have said many times before, in reality “health freedom” is a sham. In reality, “health freedom” is not an argument made for the benefit of the consumer; it’s an argument made for the benefit of the sellers of supplements. In practice “health freedom” really means freedom for quacks from any pesky laws and regulations that would prevent them from exercising their quackery.

“Personalized medicine.” You’ve probably heard the term. It’s a bit of a buzzword these days and refers to a vision of future medicine in which therapies are much more tightly tailored to individual patients than they currently are. That’s not to say that as physicians we haven’t practiced personalized medicine before; certainly we have. However it has only been in the last decade or so that our understanding of genomics, systems biology, and cell signaling have evolved to the point where the vision of personalized medicine based on each patient’s genome and biology might be achievable within my lifetime.

I was thinking about personalized medicine recently because of the confluence of several events. First, I remembered a post I wrote late last year about integrating patient values and experience into the decision process regarding treatment plans. Second, a couple of months ago, Skeptical Inquirer published an execrablynihilistic article by Dr. Reynold Spector in Skeptical Inquirer in which he declared personalized medicine to be one of his “seven deadly medical hypotheses,” even though he never actually demonstrated why it is deadly or that it’s even really a hypothesis. Come to think of it, with maybe–and I’m being very generous here–one exception, that pretty much describes all of Dr. Spector’s “seven deadly medical hypotheses”: Each is either not a hypothesis, not deadly, or is neither of the two. Third, this time last week I was attending the American Association for Cancer Research (AACR) meeting in Orlando. I don’t really like Orlando much (if you’re not into Disney and tourist traps, it’s not the greatest town to hang out in for four days), but I do love me some good cancer science. One thing that was immediately apparent to me from the first sessions on Sunday and perusing the educational sessions on Saturday was that currently the primary wave in cancer research is all about harnessing the advances in genomics, proteomics, metabolomics, and systems and computational biology, as well as the technologies such as next generation sequencing (NGS) techniques to understand the biology of each cancer and thereby target therapies more closely to what biological abnormalities drive each cancer. You can get an idea of this from the promotional video the AACR played between its plenary sessions:

Which is actually a fairly good short, optimistic version of my post Why haven’t we cured cancer yet? As I mentioned before, with this year being the 40th anniversary of the National Cancer Act, as December approaches expect a lot of articles and press stories asking that very question, and I’m sure this won’t be the last time I write about this this year.(more…)

Imagine living 20 years spending 24 hours a day in a cage that tightly fits your body, not giving you room to stand up, stretch out, turn around, or move at all.

Imagine that twice a day during these years you would have a metal catheter inserted into a hole which has been cut into your abdomen, allowing the catheter to easily puncture your gall bladder, or maybe a long syringe inserted into your gall bladder, piercing through your skin again and again, by people who are not doctors.

Imagine becoming infected and cancerous because of this twice-daily physical invasion, and becoming neurotic due to your claustrophobic imprisonment.

Imagine having one or both of your hands cut off so someone can sell them for a lot of money.

Imagine you begin to chew at your hands, if you are lucky enough to have one or both left, due to your developing neuroticism, and to distract yourself from the pain you experience twice a day, every day, for your entire life.

This is reality for an estimated minimum of 12,000 bears across Asia.

— Sara Pegarella, JD

Currently, animal activists across China are up in arms because Gui Zhen Tang Pharmaceutical Corporation, a Fujian-based company that sells bear bile for use in Traditional Chinese Medicine (TCM), has tried to increase production through an initial public offering (IPO). The company is being accused of cruelty towards animals in the process of extracting their bile at an industrial scale. Bear bile, or Xiong Dan (熊胆), is an important ingredient in TCM.

Surely, Dr. Hall, the public mania for nutritional supplements is baseless. All the alleged nutrients in supplements are contained in the food we eat. And what governmental agency has oversight responsibility regarding the production of these so-call nutritional supplements? Even if one believes that such pills have value, how can the consumer be assured that the product actually contains what the label signifies? I have yet to find a comment on this subject on your otherwise informative website.

As hard as it is to believe, it’s been nearly a year since Steve Novella, Kimball Atwood, and I were invited to meet with the director of the National Center for Complementary and Alternative Medicine (NCCAM), Dr. Josephine Briggs. Depending upon the day, sometimes it seems like just yesterday; sometimes it seems like ancient history. For more details, read Steve’s account of our visit, but the CliffsNotes version is that we had a pleasant conversation in which we discussed our objections to how NCCAM funds dubious science and advocacy of complementary and alternative medicine (CAM). When we left the NIH campus, our impression was that Dr. Briggs is well-meaning and dedicated to increasing the scientific rigor of NCCAM studies but doesn’t understand the depths of pseudoscience that constitute much of what passes for CAM. We were also somewhat optimistic that we had at least managed to communicate some of our most pressing practical concerns, chief among which is the anti-vaccine bent of so much of CAM and how we hoped that NCCAM would at least combat some of that on its website.

Looking at the NCCAM website, I see no evidence that there has been any move to combat the anti-vaccine tendencies of CAM by posting pro-vaccination pieces or articles refuting common anti-vaccine misinformation. Of all the topics we discussed, it was clearest that everyone, including Dr. Briggs, agreed that the NCCAM can’t be perceived as supporting anti-vaccine viewpoints, and although it doesn’t explicitly do so, neither does it do much to combat the anti-vaccine viewpoints so ingrained in CAM. As far as I’m concerned, I’m with Kimball in asserting that NCCAM’s silence on the matter is in effect tacit approval of anti-vaccine viewpoints. Be that as it may, not long afterward, Dr. Briggs revealed that she had met with homeopaths around the same time she had met with us, suggesting that we were simply brought in so that she could say she had met with “both sides.” Later, she gave a talk to the 25th Anniversary Convention of the American Association of Naturopathic Physicians (AANP), which is truly a bastion of pseudoscience.

In other words, I couldn’t help but get the sinking feeling that we had been played. Not that we weren’t mildly suspicious when we traveled to Bethesda, but from our perspective we really didn’t have a choice: if we were serious about our mission to promote science-based medicine, Dr. Briggs’ was truly an offer we could not refuse. We had to go. Period. I can’t speak for Steve or Kimball, but I was excited to go as well. Never in my wildest dreams had it occurred to me that the director of NCCAM would even notice what we were writing, much less take it seriously enough to invite us out for a visit. I bring all this up because last week NCCAM did something that might provide an indication of whether it’s changed, whether Dr. Briggs has truly embraced the idea that rigorous science should infuse NCCAM and all that it does, let the chips fall where they may. Last week, NCCAM released its five year strategic plan for 2011 to 2015.

I must admit that I have a bit of a love-hate relationship with breast implants. On the one hand, as a breast cancer surgeon, I see them as a major benefit to my patients who are unfortunate enough to require mastectomy in order to control their disease. The armamentarium of techniques for reconstructing breasts after mastectomy generally falls into one of two categories, either various form of muscle flaps or breast implants. However, some women are, for various reasons, not eligible for various muscle flap reconstructions. That leaves either breast implants–or nothing. Certainly, some women are perfectly fine with no reconstruction after mastectomy, but many, if not most, women are not. For these women, it would be difficult to overstate how much of a boon to body image and self-esteem reconstruction can be, particularly given how much better at it plastic surgeons have become over the last couple of decades.

On the other hand, breast implants make my life as a breast cancer surgeon more difficult for a variety of reasons. First, they tend to make mammography more difficult by obscuring part of the breast, thus decreasing the sensitivity of mammography. Good mammography facilities can get around this to some extent by using various displacement techniques, but it takes some effort, and it doesn’t completely correct the problems that implants cause for mammographic screening. Moreover, when a woman who has had implants placed for cosmetic reasons comes to see me for a breast mass or an abnormal mammogram, the presence of the implants can complicate treatment decisions. If the abnormality or mass is close to the implant, we worry about rupturing it in the process, particularly if the implant is not below the pectoralis major muscle. Even when the implant is subpectoral, the muscle overlying it frequently ends up being so stretched out that the muscle in essence forms part of the capsule around the implant and ends up being a lot thinner than you might expect. Let me tell you, my anal sphincter tone is always much tighter when operating near an implant, particularly a silicone implant. True, I’m perfectly capable of removing an implant if it’s accidentally ruptured, but such an outcome is not desirable, particularly with silicone implants, where cleaning up the leaking silicone can be difficult.

It doesn’t help that silicone breast implants have been the subject of controversy since the late 1980s and early 1990s, when thousands of women with silicone implants reported a variety of ailments, including autoimmune disease and a variety of other systemic illnesses. These reports led to a rash of lawsuits and, ultimately, the banning of silicone breast implants for general use in 1992. After that, silicone breast implants were only permitted in women requiring breast reconstruction or women enrolled in clinical trials studying breast implants. This ban was partially lifted in 2006, as evidence accumulated that the claims of autoimmune diseases and increased cancer risk due to silicone breast implants were not supported by clinical and scientific evidence and two products made by Allergan Corp. (formerly Inamed Corp.) and Mentor Corp. Not surprisingly, given that the furor over silicone breast implants as a cause of autoimmune and other systemic diseases is based on about as much solid scientific evidence as the antivaccine furor over vaccines as a cause of the “autism epidemic,” there was widespread criticism of this decision. Even now, it is not difficult to find articles about breast implants with titles like Breast Implants: America’s Silent Epidemic and websites like the Humantics Foundation and Toxic Breast Implants . I do note, however, that the number of such sites and articles does appear to be declining and, at least to my impression, seems to have decreased markedly over the last 10 years or so.

Having reviewed the literature and found evidence for a link between silicone breast implants and the systemic diseases attributed to them to be incredibly weak at best, I had little problem with the FDA’s decision. Actually, the only thing I had a problem with at the time, my opinions of how breast implants interfere with breast cancer detection and treatment notwithstanding, is that the FDA was probably being more cautious than the evidence warranted after 14 years.

European veterinary groups have long been more skeptical about “alternative” veterinary practices than their American counterparts. For example, the European Board of Veterinary Specialties refuses to grant continuing education credits for non-scientific endeavors attempting to masquerade as a way to improve one’s clinical knowledge, and the practice of veterinary homeopathy is forbidden in Sweden.

Now comes good news (for pets, and pet owners), out of the UK. In an effort to improve animal health and welfare, the Veterinary Medicines Directorate’s (VMD) has targeted “alternative” remedies, which, of course, pose both real and potential dangers to pets. The VMD is the body responsible for the authorization of veterinary medicinal products in the United Kingdom.

Specifically, the VMD is targeting a number of unauthorized products that lack scientific proof of effectiveness, including:(more…)

My stimulant of choice is coffee. I started drinking it in first-year university, and never looked back. A tiny four-cup coffee maker became my reliable companion right through graduate school. But since I stopped needing to drink a pot at a time, an entirely new category of products has appeared — the energy drink. Targeting students, athletes, and others seeking a mental or physical boost, energy drinks are now an enormous industry: from the first U.S. product sale in 1997, the market size was $4.8 billion by 2008, and continues to grow. (1)

My precious coffee effectively has a single therapeutic ingredient, caffeine. Its pharmacology is well documented, and the physiologic effects are understood. The safety data isn’t too shabby either: it’s probably not harmful and possibly is even beneficial. (I’m talking about oral consumption — no coffee enemas. Please.) In comparison, energy drinks are a bewildering category of products with an array of ingredients including caffeine, amino acids, vitamins, and other “natural” substances and assorted “nutraceuticals,” usually in a sugar-laden vehicle (though sugar-free versions exist). Given many products contain chemicals with pharmacologic effects, understanding the risks, signs of adverse events, and potential implications on drug therapy, are important.

So are energy drinks just candied caffeine delivery systems? Or are these syrupy supplements skirting drug regulations?